<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974621212422</udiDi>
    <basicUdiDi>697462121AiNAMY</basicUdiDi>
    <tradeName>Nucleic Acid Extracting System</tradeName>
    <deviceName>Nucleic Acid Extracting System</deviceName>
    <manufacturerName>Aikang MedTech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027272</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AiNA32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:04:28.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974613760160</udiDi>
    <basicUdiDi>697461376020004TE</basicUdiDi>
    <tradeName>06974613760160</tradeName>
    <deviceName>Liferiver Intelligent Molecular Mobile Mini-Lab</deviceName>
    <manufacturerName>Shanghai ZJ Bio-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023075</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZJYY-D-20220E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:02:34.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974561520113</udiDi>
    <basicUdiDi>697456152NFAST32ABE</basicUdiDi>
    <tradeName>Uni-medica</tradeName>
    <deviceName>Nucleic Acid Extractor</deviceName>
    <manufacturerName>Shenzhen Uni-medica Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022946</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15.09.002.02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:28:59.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565035</udiDi>
    <basicUdiDi>697454156003KX</basicUdiDi>
    <tradeName>06974541565035</tradeName>
    <deviceName>Automated Nucleic Acid Extraction System</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AU1001</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:28:08.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018025</udiDi>
    <basicUdiDi>697432301YQ002FF</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction and Real-Time PCR System</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction and Real-Time PCR System</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP112401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:54:35.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974149860143</udiDi>
    <basicUdiDi>69741498614YV</basicUdiDi>
    <tradeName>06974149860143</tradeName>
    <deviceName>Ultrafast Real-Time PCR System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H622202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:10.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974149860112</udiDi>
    <basicUdiDi>69741498611YP</basicUdiDi>
    <tradeName>06974149860112</tradeName>
    <deviceName>Real-Time PCR System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H621103，H621104，H621105，H621106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:06.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974149860051</udiDi>
    <basicUdiDi>697414986Kingwell96LE</basicUdiDi>
    <tradeName>06974149860051</tradeName>
    <deviceName>Kingwell Automated Thermal Cycler</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H611101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:03.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974081870484</udiDi>
    <basicUdiDi>697408187AccuRaMiniM6</basicUdiDi>
    <tradeName>Real-time PCR Quantitative Analyzer</tradeName>
    <deviceName>Real-time PCR Quantitative Analyzer</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:02.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974081870477</udiDi>
    <basicUdiDi>697408187AccuRa32DJ</basicUdiDi>
    <tradeName>Real-time PCR Quantitative Analyzer</tradeName>
    <deviceName>Real-time PCR Quantitative Analyzer</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>052</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:01.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221342</udiDi>
    <basicUdiDi>697384322FQD010GR</basicUdiDi>
    <tradeName>AutoGene 9600 Automatic PCR Analysis System</tradeName>
    <deviceName>AutoGene 9600 Automatic PCR Analysis System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-A9600(EA4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:56.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221304</udiDi>
    <basicUdiDi>697384322FQD009H8</basicUdiDi>
    <tradeName>LineGene 9600 Pro Fluorescenct Quantitative Detection System</tradeName>
    <deviceName>LineGene 9600 Pro Fluorescenct Quantitative Detection System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-96A(ED2)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:55.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221298</udiDi>
    <basicUdiDi>697384322FQD008H6</basicUdiDi>
    <tradeName>careSTART™ Q1 Amplifier</tradeName>
    <deviceName>careSTART™ Q1 Amplifier</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQA-E00182</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:54.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221274</udiDi>
    <basicUdiDi>697384322NPA001JY</basicUdiDi>
    <tradeName>GenePure Pro 16H Nucleic Acid Purification System</tradeName>
    <deviceName>GenePure Pro 16H Nucleic Acid Purification System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPA-16H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:50.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221267</udiDi>
    <basicUdiDi>697384322FQD007H4</basicUdiDi>
    <tradeName>VitroCycler Fluorescent Quantitative Detection System</tradeName>
    <deviceName>VitroCycler Fluorescent Quantitative Detection System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIT-VitroCycler</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:49.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221205</udiDi>
    <basicUdiDi>697384322NPA005K8</basicUdiDi>
    <tradeName>GenePure Pro 9600 Nucleic Acid Purification System</tradeName>
    <deviceName>GenePure Pro 9600 Nucleic Acid Purification System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPAm-9600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:49.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221175</udiDi>
    <basicUdiDi>697384322FQD012GV</basicUdiDi>
    <tradeName>CentriDx Automated Nucleic Acid Analyzer</tradeName>
    <deviceName>CentriDx Automated Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CentriDx 200(EA4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:48.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843221168</udiDi>
    <basicUdiDi>697384322FQD011GT</basicUdiDi>
    <tradeName>Bioquant-96m Fluorescent Quantitative Detection System</tradeName>
    <deviceName>Bioquant-96m Fluorescent Quantitative Detection System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bioquant-96m</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:44.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843220765</udiDi>
    <basicUdiDi>697384322FQD004GW</basicUdiDi>
    <tradeName>LineGene 9600 Plus Fluorescent Quantitative Detection System</tradeName>
    <deviceName>LineGene 9600 Plus Fluorescent Quantitative Detection System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-96A(EA2)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:43.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973843220734</udiDi>
    <basicUdiDi>697384322TC001H3</basicUdiDi>
    <tradeName>GeneExplorer Thermal Cycler</tradeName>
    <deviceName>GeneExplorer Thermal Cycler</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE-96G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:42.595Z</lastUpdated>
  </row>
</eudamedExport>